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Effect of Prebiotic Intake on Adiposity, Satiety and Gut Microbiota in Overweight and Obese Children

NCT ID: NCT02125955

Last Updated: 2017-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2017-09-30

Brief Summary

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Currently, over one third of Canadian children and youth aged five to seventeen are overweight or obese. Childhood obesity leads to increased risks of co-morbidities such as type 2 diabetes, fatty liver disease, cardiovascular disease and certain types of cancers. Changes in the food supply have been linked to obesity and include a decrease in the intake of dietary fiber. Prebiotic fibers are a group of non-digestible carbohydrates that modulate the composition and actions of the gut microbiota and have been shown to reduce body fat and energy intake in overweight and obese adults. The investigators hypothesis is that prebiotic fiber intake in overweight and obese children will similarly result in improvements in body composition and reduced energy intake.

Detailed Description

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Obesity in the pediatric population is a primary public health concern given that overweight and obesity in childhood continues into adulthood. Consumption of high-fat, calorie-dense diets do not provide individuals with the suggested daily intake of many important nutrients. This is especially true for dietary fiber which has positive health benefits such as roles in weight management. A form of dietary fiber with links to obesity treatment/prevention is prebiotic fiber. In the gut, there are many bacteria which have been shown to affect a person's health depending on the type and number of each type of bacteria. The role of prebiotic fiber is to increase the number of beneficial bacteria which in turn promotes health. Studies in humans have shown that prebiotic fiber is effective at reducing body fat and food intake in overweight and obese adults. The aim of this study is to see if prebiotic fiber can provide the same benefits to overweight and obese children. Since weight management becomes increasingly difficult as a person ages, treatments that promote weight maintenance at an early age are critically needed.

Conditions

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Overweight Obesity

Keywords

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Pediatric Overweight Obesity Gut microbiota Adiposity Prebiotic Dietary fiber

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Prebiotic fiber

The intervention group will consume an 8 gram dose of prebiotic fiber one time per day approximately 30 minutes prior to their evening meal.

Group Type EXPERIMENTAL

Prebiotic fiber

Intervention Type DIETARY_SUPPLEMENT

Dissolved in water.

Placebo

The placebo group will consume an isocaloric dose of placebo (maltodextrin; 3.3 grams) one time per day approximately 30 minutes prior to their evening meal.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Dissolved in water

Interventions

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Prebiotic fiber

Dissolved in water.

Intervention Type DIETARY_SUPPLEMENT

Placebo

Dissolved in water

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Synergy 1 (oligofructose enriched inulin) Maltodextrin

Eligibility Criteria

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Inclusion Criteria

* Boys and girls between the ages of 7-12 years old
* BMI percentiles \>85th percentile for their age and sex
* Tanner stage of ≤ 3, girls premenarche

Exclusion Criteria

* Tanner stage of \>3 or girls postmenarchal
* Use of antibiotics up to 3 months prior to study
* Regular prebiotic supplement and/or probiotic supplement use
* Subjects unable to provide consent (parental) or assent (child)
Minimum Eligible Age

7 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Alberta Children's Hospital

OTHER

Sponsor Role collaborator

University of Calgary

OTHER

Sponsor Role lead

Responsible Party

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Dr. Raylene Reimer

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Raylene A Reimer, PhD, RD

Role: PRINCIPAL_INVESTIGATOR

University of Calgary

Locations

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University of Calgary

Calgary, Alberta, Canada

Site Status

Countries

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Canada

References

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Nicolucci AC, Hume MP, Martinez I, Mayengbam S, Walter J, Reimer RA. Prebiotics Reduce Body Fat and Alter Intestinal Microbiota in Children Who Are Overweight or With Obesity. Gastroenterology. 2017 Sep;153(3):711-722. doi: 10.1053/j.gastro.2017.05.055. Epub 2017 Jun 5.

Reference Type RESULT
PMID: 28596023 (View on PubMed)

Hume MP, Nicolucci AC, Reimer RA. Prebiotic supplementation improves appetite control in children with overweight and obesity: a randomized controlled trial. Am J Clin Nutr. 2017 Apr;105(4):790-799. doi: 10.3945/ajcn.116.140947. Epub 2017 Feb 22.

Reference Type RESULT
PMID: 28228425 (View on PubMed)

Other Identifiers

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UC-1026386

Identifier Type: -

Identifier Source: org_study_id